ACUSON SC2000 PRIME Ultrasound System - Mainframe (2018-01-31)

Starting date:

January 31, 2018

Posting date:

February 16, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66006

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  Reason
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  Affected products

Affected products

ACUSON SC2000 PRIME Ultrasound System - Mainframe

Reason

Siemens is notifying users of a potential issue with the ACUSON SC2000 ultrasound system with software versions VB10A, VB10B, VB10D and VB10E. The 3D eSie PISA volume analysis application quantifies valvular regurgitation. While imaging with the Z6Ms volume transesophageal echocardiography transducer, this application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.

Affected products